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An Evaluation Of Healthy Ankle Motion And Morphology

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ClinicalTrials.gov Identifier: NCT03619382
Recruitment Status : Unknown
Verified March 2019 by Paragon 28.
Recruitment status was:  Active, not recruiting
First Posted : August 7, 2018
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Focus Medical Design and Development
Information provided by (Responsible Party):
Paragon 28

Tracking Information
First Submitted Date July 11, 2018
First Posted Date August 7, 2018
Last Update Posted Date March 20, 2019
Actual Study Start Date July 16, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 6, 2018)
Relative rotations of bones [ Time Frame: 1 day ]
Determine relative tri-axial rotations between bones of the foot and ankle using reconstructed 3-dimensional computer models. All rotations will be measured in degrees (°).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 6, 2018)
  • Relative translations of bones [ Time Frame: 1 day ]
    Determine relative multi-directional translation between bones of the foot and ankle using reconstructed 3-dimensional computer models. All translations will be measured in mm.
  • Morphology - size and shape of the bones of the foot and ankle [ Time Frame: 1 day ]
    Evaluate the size and shape of the bones of the foot and ankle using reconstructed 3-dimensional computer models relative to height, weight, body mass index and gender. All distances will be measured in mm.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Evaluation Of Healthy Ankle Motion And Morphology
Official Title An Evaluation Of Healthy Ankle Motion And Morphology In Different Phases Of Simulated Gait Using A Weight-bearing CBCT Scan
Brief Summary Determine motion and morphology of the healthy ankle during simulated gait.
Detailed Description Healthy volunteers will undergo weight-bearing, cone beam CT scans of their foot/ankle during 3 phases of simulated gait. Motion and morphology of the foot and ankle will be quantified and analyzed.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Volunteers who have a healthy ankle
Condition Healthy Ankle
Intervention
  • Radiation: Cone Beam Computed Tomography
    Computer tomography (CT) of the foot/ankle for determination of motion and morphology
  • Radiation: Radiographs
    Standard radiographs of the foot/ankle as part of the screening criteria
Study Groups/Cohorts Healthy
Subjects identified to have a healthy foot/ankle
Interventions:
  • Radiation: Cone Beam Computed Tomography
  • Radiation: Radiographs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: August 20, 2018)
19
Original Estimated Enrollment
 (submitted: August 6, 2018)
25
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. The subject self-reports having a right healthy ankle.
  2. The subject agrees to comply with the requirements of the study and complete the study measures.
  3. The subject is between the ages of 18 and 65.
  4. The subject is willing to provided written informed consent.

Exclusion Criteria:

  1. The subject is pregnant.
  2. The subject reports having been diagnosed with any form of diabetes.
  3. The subject reports having surgery on the right foot, right ankle and/or right knee.
  4. The subject reports a history of repeated ankle sprains or injuries to the right ankle.
  5. The subject reports a history of instability of the right ankle.
  6. The subject reports chronic or recurring pain of the right ankle.
  7. The subject is: a prisoner, unable to understand what participation in the study entails, mentally incompetent, and/or known abuser of alcohol and/or drugs.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03619382
Other Study ID Numbers P10-SP-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Paragon 28
Study Sponsor Paragon 28
Collaborators Focus Medical Design and Development
Investigators
Principal Investigator: James Clancy, DPM Orthopedic Center of Palm Beach County
PRS Account Paragon 28
Verification Date March 2019